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How Johnson & Johnson’s Vaccine Differs From Pfizer and Moderna’s


A third effective weapon was added to America’s arsenal against the coronavirus on Saturday when the Food and Drug Administration granted emergency use authorization for a vaccine developed by Johnson & Johnson.

The company said it would start shipping millions of doses early this week, and would provide the United States with 100 million doses by the end of June. Together with 600 million doses of the nation’s first two authorized vaccines, made by Pfizer-BioNTech and Moderna, that are due to be delivered over the next four months, that ought to be enough to cover every American adult who wants to be vaccinated.

The new vaccine differs markedly from the two already in use in the United States. Here is how they compare.

The Johnson & Johnson vaccine is administered in a single shot, while the Pfizer-BioNTech and Moderna vaccines are given in two shots several weeks apart.

The Johnson & Johnson vaccine uses a different method to prime the body to fight off Covid-19: a viral vector called Ad26. Viral vectors are common viruses that have been genetically altered so that they do not cause illness but can still cause the immune system to build up its defenses. The Pfizer-BioNTech and Moderna vaccines use messenger RNA to do that.

The Johnson & Johnson vaccine is rated as highly effective at preventing serious illness and death, as the Pfizer-BioNTech and Moderna vaccines are. It is also very effective at preventing milder illness, though a bit less so than those two. It appears to do well against the highly contagious B.1.351 variant, first identified in South Africa, that has given at least one other vaccine candidate trouble.

The Johnson & Johnson vaccine does not have to be stored at extremely low temperatures like the Pfizer-BioNTech vaccine. It can safely be kept in an ordinary refrigerator for three months, much longer than the Moderna vaccine, which spoils after a month if not kept frozen.

The Johnson & Johnson vaccine appears to be less prone than the Pfizer-BioNTech and Moderna vaccines to trigger the kinds of side effects that require monitoring after the injection, which may make it more suitable for use at drive-through vaccination sites. There have been reports that side effects tend to be felt more strongly after second doses, which the Johnson & Johnson vaccine does not require.



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Pfizer and Moderna pledge a massive vaccine surge



“Because of the dire need to vaccinate more people, we have ramped up production of doses,” John Young, Pfizer’s chief business officer, told the House Energy and Commerce oversight and investigations subcommittee in prepared testimony.

But achieving a surge on that scale remains daunting. Pfizer and Moderna, the companies with the only authorized vaccines so far, will need to increase their combined deliveries to date of 75 million doses to reach their promised target of 220 million shots by March 31.

That’s a goal of 28 million doses each week on average, far greater than their performance so far. The Biden administration said last week that doses allotted to states would grow from 11 million to 13.5 million per week, and it also directed 2 million doses to pharmacies, part of allocations that are expected to increase modestly again this week.

If the companies are able to meet their projections, it would signal the beginning of the end of a period of deep frustration and mark faster progress against a pandemic that has claimed 500,000 lives in the United States. The slower-than-anticipated vaccine rollout has hampered progress toward vaccinating the 70 or 80 percent of the U.S. population of 330 million people required to achieve herd immunity against the coronavirus.

Pfizer and Moderna, which both make mRNA vaccines, fell far short of the delivery schedules set by the Trump administration in December, when their vaccines received emergency authorization from the Food and Drug Administration. But both companies are expressing confidence in their latest promises after continuing to invest in manufacturing and steadily advancing production. Combined, the two companies have contracts to provide 600 million doses, which they say will be ready by the end of July.

Pfizer, which is partnered with Germany’s BioNTech in production of its vaccine, has laid out an aggressive timeline for boosting deliveries in coming weeks, according to Young’s advance testimony. The company has been pouring money into doubling batch sizes and adding manufacturing suites, as well as making its own supply of crucial raw materials called lipids and creating its own finish-fill capacity to put batches of vaccine into vials for shipment.

Pfizer reported last week during President Biden’s visit to its Kalamazoo, Mich., manufacturing plant that it had reduced manufacturing time from 110 days to about 60 days.

Pfizer also benefited from an FDA decision that recognized “overfill” in its vials as a sixth dose, creating a 20 percent increase in its deliveries.

Uneven weekly production is among the reasons the Biden administration has not issued new promises beyond its initial goal of delivering 100 million shots within the president’s first 100 days, despite drugmakers’ more ambitious promises, according to a senior administration official who, like other officials addressing production schedules, spoke on the condition of anonymity because of the matter’s sensitivity.

The administration is aiming to hold the companies to their commitments, the official said, while maintaining “collaborative enough relationships where they will share risks, as opposed to putting a gun to their head and saying, ‘You have to do X or Y and we don’t want to hear anything about it.’ ”

Two other Biden administration officials said it was unlikely that 220 million vaccine doses would be distributed by the end of March, even if a quantity approaching that total was allocated to states and other jurisdictions without being shipped by then. One official said just shy of 200 million doses was a more realistic estimate.

The potential for a supply pinch as the first quarter draws to a close late next month could represent a smaller-scale reprise of problems that bedeviled the Trump administration at the end of last year. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, estimated Dec. 20 at a meeting of a CDC advisory panel that there would be 40 million doses delivered in December, 60 million in January and 100 million in February — projections that proved much higher than reality.

Publicly posted CDC data indicates that about 75 million doses had been delivered as of Monday — about 10 million fewer doses than the companies said in their prepared testimony that they have provided.

Federal officials said delivered doses were split about evenly between the two companies. About 44 million people have received shots, with nearly 20 million of those people having received both required injections, for a total of about 64 million shots.

Pfizer’s promise is to provide 120 million doses by the end of March, while Moderna has said it will supply 100 million doses by then. To meet its target, Pfizer would have to release more than 2 million doses a day, or more than 14 million a week, for the next five weeks. The company currently is providing about 9 million doses a week, according to one of the federal officials involved in the vaccine effort, with the expectation that it can climb steadily to about 13 million doses per week by the beginning of April. Moderna is expected to level out at about 10 million per week, the official said.

Moderna said in its prepared testimony that it had produced 45 million doses as of this week, which leaves 55 million, or more than 10 million per week, to reach its goal of 100 million by March 31.

“As we work to meet these goals, we are continually learning and working closely with our partners and the federal government to identify ways to address bottlenecks and accelerate our production,” Moderna President Stephen Hoge said in prepared remarks.

The single-shot Johnson & Johnson vaccine, which is expected to be authorized for emergency use as soon as this weekend, also will provide a significant boost, though federal officials say only a few million doses will immediately be available.

After that slow start, the company will deliver 20 million doses by the end of March, Johnson & Johnson said in its prepared testimony. By the end of April, the company is projected to have delivered nearly 60 million doses to the United States, officials said — well on its way to meet its promise of supplying 100 million doses by the end of June.

“The production of our vaccine is a highly complex process that requires very particular capabilities and experiences,” Richard Nettles, vice president of U.S. medical affairs for Johnson & Johnson’s Janssen division, said in his prepared testimony. “As a result, there are significant challenges inherent in scaling manufacturing output and accelerating the timeline needed for a coronavirus vaccine.”

To prepare for an expected surge of vaccine, federal officials are organizing mass vaccination sites in stadiums and parks throughout the country. They are directing more vaccine supply directly to retail pharmacies. And they are telling states that, within a few months, supply of the shots could begin to outpace demand, requiring a redoubled effort to persuade reluctant people to be immunized.

Andy Slavitt, a White House senior adviser on the coronavirus response, said he spends as much time on demand-side models as on those addressing supply shortages. Behavioral factors influencing vaccine hesitancy, he said, present a “different but no less critical challenge than getting a factory to produce more supply.”

Prepared testimony for the House hearing provided a more detailed public look inside the production of vaccines by companies that are traditionally secretive about their production procedures and data. Lack of visibility into production schedules for Pfizer, in particular, has been a source of frustration for federal officials, although senior Biden administration officials maintain they have stronger communication lines into the manufacturing process than did the Trump administration. That includes in-person monitoring of manufacturing “as needed,” according to a senior Biden administration official who spoke on the condition of anonymity because of the sensitivity of the matter.

One of the central aims of Biden’s team was to provide states with better supply forecasting so they could prepare the needed workforce, determine eligibility groups and set public expectations. In the first several weeks of the rollout, state officials complained of being caught off guard by last-minute changes to their allocations. Less than a week after Biden took office, the administration increased weekly allocations by 16 percent and pledged to provide estimates of anticipated supply three weeks in advance.

That has proved more challenging than the president’s team expected, in large part because production increases have been uneven. Biden’s advisers have been able to notify states of increased supply each week — typically on calls with governors led by Jeff Zients, the White House’s coronavirus coordinator — but the three-week estimates have become less reliable.

Much of the difficulty in supply forecasting owes to fill-finish bottlenecks, which federal officials describe as the most important obstacle to increasing manufacturing.

Last week, Moderna disclosed what it described as “short-term delays in the final stages of production and release of filled vials” encountered by its production partner, New Jersey-based Catalent. The same company is performing fill-finish functions for Johnson & Johnson. Moderna stressed that it would be able to meet monthly targets, and federal officials said there was no decrease in supply available to states. Moderna has asked the FDA to permit it to add up to five more doses in each of its vials, which currently hold 10 doses, which would improve finish-fill capacity by 50 percent.

Officials in states throughout the country maintain they have the ability to administer as much as five times the amount of vaccine they are receiving. The promise of a flood of shots, they say, could help them end the pandemic.

“We have the capacity and infrastructure in place to drastically ramp up how fast we can get shots in arms in Connecticut if we have the supply to make it happen,” said Connecticut Gov. Ned Lamont (D). “The Biden administration has provided predictability and increased numbers of doses, supporting our efforts at the state level, and so long as that continues, the light at the end of the tunnel gets closer and closer.”



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U.S., Pfizer increase the number of coronavirus vaccines



The additional doses are unlikely to mean an expansion of early access to the shots, which are being rationed for health-care workers and long-term care residents and staff as the coronavirus strains the country’s medical system. But the forthcoming larger supply — increasing by one-third the amount of vaccine available by mid-2021 — averts the possibility of a devastating shortfall in the spring and summer, right as the government was anticipating being able to make immunization available to wider segments of the public.

Pfizer and the biotechnology company Moderna, which have received federal authorization to distribute coronavirus vaccines on an emergency basis, have now promised, between them, to provide the United States with 400 million doses. That would leave the country short of shots for about 55 million adults, based on Census Bureau estimates, though federal officials say they anticipate additional vaccine candidates more than making up the difference.

“With these 100 million additional doses, the United States will be able to protect more individuals and hopefully end this devastating pandemic more quickly,” Albert Bourla, Pfizer’s chief executive, said Wednesday.

According to data maintained by the Centers for Disease Control and Prevention, more than 1 million vaccine doses had been administered in the United States by Wednesday. Nearly 10 million doses had been distributed, mainly to large hospital systems equipped to inoculate large numbers of ICU nurses, respiratory therapists, service workers and others battling an intensifying surge of infections.

“I think it’s a very good pace,” Gen. Gustave Perna, the chief operating officer of the Trump administration’s Operation Warp Speed, told reporters on Wednesday, saying the number of people vaccinated is larger than federal records suggest because it takes time for vaccinations to be logged.

Perna said 12 states began vaccinations in long-term care facilities this week, through a partnership with CVS and Walgreens, and another 13 states would begin next week. After an uproar from state leaders last week, who said their allocations had been cut without explanation, Perna said the federal government would ship 4.67 million vaccine doses to thousands of sites next week. Shots have been slower to begin in nursing homes and similar settings because of the process of getting consent, sometimes needing to involve residents’ relatives.

The first vaccines are being given as the country faces a rapid surge in infections and deaths and some hospitals are exceeding their capacities. Over the past week, an average of 2,666 Americans died each day of covid-19, the illness caused by the virus — a record. More than 119,500 patients were hospitalized with the virus Wednesday, in another all-time high for the country.

As of Wednesday, the coronavirus has infected 18.4 million people in the United States and killed more than 325,000.

Adding to the unease in the midst of a burst of Christmas-related travel was the spread in Britain of new variants of the coronavirus. Britain’s top health official announced Wednesday that two cases of yet another new coronavirus variant were found in the country. Health Secretary Matt Hancock said the new variant spreads more readily and was first detected last week by scientists in South Africa. The variant comes on top of a different permutation of the virus that has been triggering a rapid rise of cases in Britain and prompted travel restrictions, which have stymied the movement of cargo and passengers between that country and Europe.

Britain and France reached an agreement that would allow some passengers and all freight into France, as long as drivers provided negative test results for the virus. The military was managing testing sites where thousands of trucks have been stranded on the British side of the English Channel.

Britain, earlier this month, was the first country to begin administering doses of the Pfizer-BioNTech vaccine, while European drug authorities on Monday authorized its use.

Between the products from Pfizer and Moderna, U.S. officials say they anticipate being able to deliver at least a first shot of the two-dose regimens to 100 million Americans by the end of February. Pfizer and Moderna have both promised that half of their doses will be available to the government for distribution by April 1. The shots will be free to anyone who receives them.

The leaders of Operation Warp Speed, the Trump administration’s initiative to speed the development of vaccines and therapeutics, have stressed that other vaccine candidates will soon supplement this supply. Speaking to reporters on Wednesday, Moncef Slaoui, the initiative’s scientific adviser, singled out Johnson & Johnson’s vaccine as a promising product, predicting there would be “redundancy” of shots rather than a shortage.

The agreement reached Wednesday with Pfizer also includes options for the government to purchase an additional 400 million doses of that vaccine.

As part of the agreement, the government has agreed to use the Defense Production Act, a Korean War-era law allowing the designation of certain supplies as essential in wartime or other national emergencies, to help the pharmaceutical giant accelerate production.

The Trump administration has used the law on occasion, including to increase production of masks and ventilators. But the administration has drawn criticism, including from public health experts, for not using the law more broadly or consistently for the production of personal protective equipment that has remained in short supply or to increase the availability of tests earlier this year.

President-elect Joe Biden has called on the Trump administration to purchase more vaccine and to make greater use of the Defense Production Act for the raw materials needed by pharmaceutical companies and other pandemic-fighting purposes.

Pfizer has been stressing for several months its eagerness for the administration to help it gain vaccine-making supplies through this law, said people familiar with the negotiations, because some of the materials it needed had been snapped up by companies given priority under Operation Warp Speed.

Pfizer was the only company that did not take government money for research and development of a vaccine, which meant U.S. officials have had less insight into aspects of its manufacturing process, federal officials have said, and less certainty about where the company’s doses would be sold. Pfizer, for its part, had indicated to the government that it would be able to provide 70 million doses in the second quarter and an additional 30 million in the third quarter — but that it might be able to get to 100 million doses more quickly if it received help gaining access to certain raw materials.

Under Wednesday’s agreement, Pfizer is adhering to its original time frame even with government help, pledging to provide 70 million additional doses by June 30 and the other 30 million by the end of July.

The administration had earlier turned down entreaties to lock down more of the supply, causing Pfizer to commit hundreds of millions of doses to other countries. When administration officials recently returned to the drugmaker seeking to buy another 100 million doses, the question of support under the Defense Product Act became central to negotiations.

For vaccine developers, priority under the Defense Production Act means assistance in obtaining raw materials and producing supplies such as glass vials and syringes, as well as “specialty tooling and staff” to enhance plants and production lines, said Michael Pratt, a spokesman for Operation Warp Speed. The law is only invoked for contracts delivering supplies domestically, said an administration official familiar with its usage. Members of the Trump administration have complained this fall of lacking “visibility” into Pfizer’s manufacturing process.

“It does make sense that with earlier Warp Speed contracts, the companies would have worked out with the government what raw materials they needed and how priority through the DPA could help,” said Jerry McGinn, executive director of George Mason University’s Center for Government Contracting. “It doesn’t sound unreasonable for Pfizer, when doing another contract with the government for delivery, to fold that issue in. It probably gave the government some leverage.”

With a sharply limited supply of shots for the next few months, states have been prioritizing health-care workers and the residents and staff of long-term care facilities, with certain other front-line workers and people aged 75 and older expected to gain access in the next phase. In one bright spot for hospitals receiving the initial shipments of the Pfizer-BioNTech vaccine last week, some health-care providers discovered they could get as many as seven doses out of vials they were told contained only five doses of the precious vaccine.

The Food and Drug Administration is planning to reissue the emergency use authorization soon for the vaccine to make clear that six doses can be extracted from a vial, according to people familiar with the matter who spoke on the condition of anonymity because they were not authorized to share details publicly. The extra dose can be acquired by using a kind of syringe, called a low dead space syringe, which cuts medication waste.

Even in parts of the country with the most dire need, however, gaps are already emerging in access to the shots. Because of the size of each batch, and the ultracold storage requirements in the case of the Pfizer-BioNTech vaccine, states are turning to large hospital systems to inoculate their own staff. Other providers, said Gustavo Friederichsen, chief executive of the Los Angeles County Medical Association, are asking: “Where do I fit in this plan?”

Laurie McGinley and Paul Schemm contributed to this report.



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Pfizer To Supply U.S. With Additional 100 Million Doses Of COVID-19 Vaccine



WASHINGTON (AP) — Pfizer and BioNTech will supply the U.S. with an additional 100 million doses of the COVID-19 vaccine under a new agreement.

The drugmakers said Wednesday that they expect to deliver all the doses by July 31 in the nearly $2 billion deal.

Pfizer already has a contract to supply the government with 100 million doses of its vaccine.

Under the $2 billion deal announced Wednesday, the companies will deliver at least 70 million of the additional doses by June 30, with the remaining 30 million doses to be delivered no later than July 31. The government also has the option to acquire up to an additional 400 million doses.

Pfizer’s vaccine was the first to gain approval from the Food and Drug Administration and initial shipments went to states last week. It has now been joined by a vaccine from Moderna, which was developed in closer cooperation with scientists from the National Institutes of Health.

Moderna’s vaccine comes under the umbrella of the government’s own effort, which is called Operation Warp Speed. That public-private endeavor was designed to have millions of vaccine doses ready and available to ship once a shot received FDA approval.

The deal with Pfizer moves the nation closer to the goal of vaccinating all Americans.

A law dating back to the Korean War gives the government authority to direct private companies to produce critical goods in times of national emergency. Called the Defense Production Act, it’s expected to be invoked to help Pfizer secure some raw materials needed for its vaccine.

Pfizer already had a contract to supply the government with 100 million doses of its vaccine under Operation Warp Speed, but government officials have said it’s more of an arms-length relationship with the company and they don’t have as much visibility into its operations.

Health and Human Services Secretary Alex Azar said last week that the government was negotiating with Pfizer for more doses, but details provided Tuesday about the company’s desire for better access to supplies are new.

“With these 100 million additional doses, the United States will be able to protect more individuals and hopefully end this devastating pandemic more quickly,” said Pfizer CEO Albert Bourla. “We look forward to continuing our work with the U.S. government and healthcare providers around the country.”

The vaccine from Pfizer and German pharmaceutical BioNTech immediately raised hopes of taming a pandemic that has killed nearly 320,000 people in the U.S. and hobbled much of the national economy. Health care workers and nursing home residents topped the list as local TV stations across the country began broadcasting scenes of the first vaccinations. Some polls show skepticism about getting vaccinated may be easing.

After early failures with testing, Trump administration officials are hoping to write a very different ending with vaccines. Operation Warp Speed has financed the development, manufacture and distribution of millions of doses, with the goal of providing a free vaccine to any American who wants one.

Operation Warp Speed is on track to have about 40 million doses of vaccine by the end of this month, of which about 20 million would be allocated for first vaccinations. Distribution of those doses would span into the first week of January. Both the Pfizer and Moderna vaccines require two shots to be fully effective.

The New York Times first reported the new details of negotiations between Pfizer and the Trump administration.

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Pfizer Nears Deal to Provide More Vaccine Doses


The Trump administration and Pfizer are close to a deal under which the pharmaceutical company would bolster supply of its coronavirus vaccine for the United States by at least tens of millions of doses next year in exchange for a government directive giving it better access to manufacturing supplies, people familiar with the discussions said.

An agreement, which could be announced as early as Wednesday, would help the United States at least partly offset a looming vaccine shortage that could leave as many as 110 million adult Americans uncovered in the first half of 2021.

So far, only two pharmaceutical companies — Pfizer and Moderna — have won federal authorization for emergency distribution of Covid-19 vaccines, and most of what they are capable of producing for the next six months has already been allocated through contracts with the United States and other governments.

In the negotiations, the government is asking for 100 million additional doses from Pfizer from April through June. The company has signaled that it should be able to produce at least 70 million, and perhaps more, if it can get more access to supplies and raw materials.

To help Pfizer, the deal calls for the government to invoke the Defense Production Act to give the company better access to roughly nine specialized products it needs to make the vaccine. One person familiar with the list said it included lipids, the oily molecules in which the genetic material that is used in both the Moderna and Pfizer vaccines is encased.

Pfizer first started asking for the government’s help in obtaining supplies as early as September and has been unhappy about the lack of response, according to documents reviewed by The New York Times.

Moderna and other companies that worked more closely than Pfizer with the administration through its Operation Warp Speed to develop their vaccines already receive favored treatment from suppliers, putting Pfizer at a disadvantage. That includes two companies — Sanofi and Novavax — that have yet to begin large-scale clinical trials in the United States.

Pfizer and the administration have been negotiating for more doses from Pfizer for more than a month. But a host of other issues have stood in the way of a deal, including Pfizer’s commitments to other nations that moved faster than the United States to lock in a big supply, according to people familiar with the situation.

Pfizer already has a federal contract, signed in July, to deliver 100 million doses of its vaccine by the end of March. Moderna has the same agreement, and has also pledged to sell the government 100 million more doses in the second quarter of the year, from the start of April to the end of June.

Because the Pfizer and the Moderna vaccine both require two doses, that supply would cover only 150 million Americans out of the roughly 260 million who are eligible at the moment to be vaccinated. (Moderna’s vaccine is now restricted to those 18 and over, and Pfizer’s is limited to those 16 and over.)

If Pfizer provides another 100 million doses, that would leave about 60 million eligible Americans uncovered in the first half of the year. Other producers could also cover the shortfall should their vaccines prove successful.

It is not clear how many more doses Pfizer can quickly produce even if the administration uses the Defense Production Act to clear away supply obstacles. One person familiar with the situation said the firm may only be able to deliver 70 million by the end of June, even with better access to supplies.

Had the government agreed to prioritize its supply needs earlier, one person familiar with Pfizer’s situation said, the company might be better positioned now to fully meet the demands. Documents reviewed by The Times showed that Pfizer officials began asking Gen. Gustave F. Perna, the chief operating officer of Operation Warp Speed, in September for help with supplies and brought up the issue repeatedly in weekly meetings.

A senior Trump administration official said the government was unwilling to intervene because Pfizer refused to promise that it would use those materials to produce vaccines solely for Americans.

“It’s our obligation under that type of priority rating to make sure that assets are used only for U.S. sales or production,” the official said, “and they weren’t willing to do that.”

People knowledgeable about the talks said General Perna had raised a different concern with Pfizer, saying the government wanted to protect its investment in the other companies under Warp Speed’s umbrella, so it did not want to grant Pfizer the same priority with supplies.

According to a report last month by the Government Accountability Office, the Defense Production Act gives the federal government vast authority over private companies, including the power to prevent supplies from being diverted to a different purpose or products from being sold overseas. The administration has granted the kind of status that Pfizer has been seeking to multiple contractors for medical supplies since the pandemic began, including companies that produce ventilators and N-95 respirators, the report states.

Because the Pfizer vaccine, developed with the German company BioNTech, is one of only two that the Food and Drug Administration has approved for emergency use, the company has had leverage in negotiating the new contract.

That advantage could erode if other vaccines are authorized. A third firm, Johnson & Johnson, is expected to announce results from its clinical trials next month. A fourth, AstraZeneca, has announced some interim results, but it has yet to fully enroll its trial in the United States.

With infections, hospitalizations and deaths surging to record levels from a pandemic that has already killed more than 320,000 Americans, the pressure on Pfizer and the government to come to terms is growing.

“The last thing we want is for this to turn acrimonious,” said Dr. Walid F. Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “This kind of corrosive back-and-forth is not helping the public feel any better about what’s going to happen in the future.”

Pfizer’s relationship with the administration has been tense for months. After he lost the election in November, President Trump accused Pfizer of deliberately slow-walking federal approval of its vaccine to hurt him politically.

Alex M. Azar II, the secretary of health and human services, and his aides have complained that Pfizer has kept the government at arm’s length, has faced production problems and has sometimes been uncooperative in negotiations.

Another snag in the relationship surfaced Friday when a European official released on Twitter — and then quickly deleted — a price list showing that vaccine shipments to the U.S. government cost a third more per dose than shipments to European customers.

Pfizer completed a deal last month to sell the European Union 200 million doses at a cost of $14.50 each. The contract signed by the Trump administration with Pfizer in July for the original 100 million doses put the price at $19.50.

It is unclear how much the United States would pay if Pfizer and the federal government struck a new deal. In a statement, Pfizer said only that the European Union’s order was its largest to date, and that Pfizer and BioNTech “are using a tiered pricing formula based on volume and delivery dates.” It declined to disclose further details of the agreement.

Pfizer executives have been frustrated because, according to people familiar with the negotiations, they repeatedly urged the federal government this summer and fall to lock in more doses early, before other nations snapped them up. Administration officials declined, later saying that Pfizer refused to commit to specific dates when it would deliver them.

The pharmaceutical firm has struggled to navigate the politics of the situation. Pfizer’s chief executive, Dr. Albert Bourla, repeatedly suggested that the firm would know if its vaccine worked by October. Mr. Trump, who saw a vaccine breakthrough as crucial to his re-election chances, initially praised Dr. Bourla as a “great guy” — then blamed the firm for his loss when the results were released after Election Day.

At the same time, the president and his top aides have claimed credit for Pfizer’s success, even though, unlike the other five vaccine makers in the Operation Warp Speed program, Pfizer did not take federal subsidies for the vaccine development or manufacturing, assuming all of the risk itself.

Pfizer has also vacillated in describing its relationship with the federal government. A top Pfizer official at one point stated that “we were never part of Operation Warp Speed,” then the company backtracked and acknowledged the firm was.

Mr. Azar alluded to the friction with Pfizer in an interview last week with CNBC, saying the federal government was willing to help Pfizer manufacture more “if they are willing to take our help.” He added, “I do wish we would just stop talking about this Pfizer thing.”

He denied that there was any threat of a vaccine shortage, saying the government had commitments for three times as many doses as it has now ordered for the first half of next year. Mr. Azar’s total appears to include either doses of vaccines that have not yet been shown to work or doses described in contract options that are not set in stone and include no firm date of delivery, or both.



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FDA investigating rare allergic reactions to Pfizer coronavirus vaccine, but says rollout will continue



The FDA said it is closely monitoring these situations and is teaming with the Centers for Disease Control and Prevention to investigate what incited these responses. While that is being investigated, the FDA is working with Pfizer to update fact sheets and prescribing information to reflect the evolving information. The FDA said that would underscore an existing requirement — that facilities administering the vaccine must be capable of immediately treating any severe allergic reaction.

The vaccine developed by the pharmaceutical giant Pfizer and the German company BioNTech passed strict safety reviews during months-long randomized clinical trials involving tens of thousands of people. But three incidents of anaphylaxis — a sudden allergic response that can be reversed quickly with medication — are a complication for officials hoping to gain public acceptance of the vaccine.

They’re also a biochemical mystery. No one knows what component of the vaccine incited the anaphylactic reactions.

“While the totality of data at this time continue to support vaccinations under the Pfizer [emergency use authorization] without new restrictions, these cases underscore the need to remain vigilant during the early phase of the vaccination campaign,” FDA vaccine expert Doran Fink said at the start of an all-day meeting of the FDA advisory committee examining a similar vaccine developed by Moderna, which is poised for emergency authorization in the coming days.

“We learned of these cases through established safety surveillance systems that worked exactly as designed, and FDA is coordinating with the CDC to further investigate the cases in the U.S., and to communicate our findings in a timely manner,” Fink said.

Fink said the data does not suggest new restrictions on use of the Pfizer-BioNTech vaccine are required. Unlike traditional vaccines, these do not include preservatives and do not include ingredients grown in chicken eggs.

Two cases of anaphylaxis occurred last week in the United Kingdom, involving health-care workers with a history of severe allergic reactions. They fully recovered after treatment.

A third incident happened Tuesday at Bartlett Regional Hospital in Juneau, Alaska. A health-care worker with no prior history of severe allergic reactions suffered shortness of breath, rapid heartbeat and flushed skin. The first symptoms began 10 minutes after receiving the vaccine injection.

The worker was treated overnight. By the next morning she was stable and not on medication. She then stayed a second night in the hospital “under observation,” according to a hospital statement. “She is still encouraging her colleagues to get the vaccine,” the statement added.

That was the first and, as of Thursday afternoon, only reported case of anaphylaxis since the vaccines began to be administered Monday nationwide.

Another employee at Bartlett Regional Hospital who received the vaccine Wednesday “experienced eye puffiness, lightheadedness, and scratchy throat ten minutes after being injected with the vaccine,” according to a statement from the city of Juneau. He was given a standard treatment of epinephrine, Pepcid and Benadryl and “felt completely back to normal within an hour and was released,” the statement said.

The hospital said that case was not considered anaphylaxis.

Vaccine expert and pediatrician Paul Offit of the Children’s Hospital of Philadelphia said Wednesday that, among all vaccines, about 1 in 1 million vaccinations triggers a severe allergic reaction. The guidance for this new vaccine requires people to be monitored for 15 minutes after the injection to see if they have a reaction, or 30 minutes if they have a history of severe allergic responses.

Milder side effects, such as fever, headache, fatigue and pain at the injection site, have also been reported by volunteers in randomized trials, particularly after the second dose and among younger people who tend to have more robust and reactive immune systems. Those side effects go away in a day or two and are not considered a cause for concern.

Tal Zaks, chief medical officer of Moderna, said at Thursday’s hearing that there are three components of the vaccine that theoretically could cause rare reactions. He said that the National Institutes of Health convened an expert panel Wednesday to discuss the possibilities.

He pointed out that several components of the Moderna vaccine — which has not been linked to any anaphylactic reactions in the randomized trials — are proprietary, and differ from components in the Pfizer-BioNTech vaccine.

“While we all say there’s a [lipid nanoparticle] here delivering mRNA; therefore, they must be the same . . . I actually think as far as the component that is likely to be the culprit here, I would not necessarily assume that,” Zaks said. “We will be looking very carefully, as has been noted, and continue to collaborate with colleagues to understand the mechanism here.”

Moderna executive Jacqueline Miller said Thursday that, after scouring a database from previous use of the same vaccine technology in trials for eight other vaccines with 1,700 people, there was a single case of an anaphylactic event reported, and it was more than two months after the shot was given. The lengthy time delay makes it unlikely that it was directly linked to the shot.

The randomized trials of both the Pfizer-BioNTech and Moderna coronavirus vaccines have not produced cases of anaphylaxis, but those trials did not permit participation by anyone with a known allergy to any component of the vaccine.

States and jurisdictions are continuing to receive deliveries of the first week’s 2.9 million Pfizer dose allocation and provide vaccinations every day. States routinely provide data to the CDC on vaccine coverage, and the CDC is awaiting the first data reports from states about vaccine administration that began Monday.

More than 1.5 million doses had been distributed, but not necessarily administered, by Thursday morning, according to the Department of Health and Human Services.

Laurie McGinley and Lena H. Sun contributed to this report.



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Moderna, Pfizer, AstraZeneca covid vaccines: What you need to know


After more than 300,000 covid-19 deaths and 16 million infections in the United States, the first coronavirus vaccine was administered to U.S. health-care workers on Dec. 14. Public health officials are hoping that at least 70 percent of the population will get one of the vaccines being rolled out so that the nation can achieve herd immunity and stop the virus’s spread. Here are answers to some frequent questions.

How does the Pfizer-BioNTech vaccine work?

The first vaccine authorized in the United States was developed by pharmaceutical giant Pfizer and the German firm BioNTech. It consists of two shots, given three weeks apart.

The Pfizer vaccine is also the first vaccine using messenger RNA technology ever approved for human use by the Food and Drug Administration. It is different from more traditional vaccines, which often use a weakened or dead version of a virus, or a laboratory-generated protein. It uses a synthesized scrap of genetic information that is wrapped in a protective fat layer to keep it from disintegrating. When it goes into cells in the muscle of the upper arm, it contains molecular instructions that tell your cells to create a protein that triggers an immune response to the spike protein on the surface of the coronavirus. This means your immune system will be prepared to eliminate the pathogen if it tries to invade.

RNA vaccines contain a strip of genetic material within a lipid bubble.

Inside the cell, ribosomes read the mRNA instructions

for the spike protein.

The cell then begins to generate copies of the spike protein.

Antigen-presenting cells (APCs) consume the viral proteins and pass viral peptides to T-helper cells.

The immune system, presented with the peptide, learns to recognize the virus and releases cytotoxic

T cells and B cells.

Cytotoxic T cells detect and eliminate virus-infected cells.

Antibodies from B-cells block the virus from infecting healthy cells.

RNA vaccines contain a strip of genetic material within a lipid bubble.

Inside the cell, ribosomes read the mRNA instructions

for the spike protein.

The cell then begins to generate copies of the spike protein.

Antigen-presenting cells (APCs) consume the viral proteins and pass viral peptides to T-helper cells.

The immune system, presented with the peptide, learns to recognize the virus and releases cytotoxic

T cells and B cells.

Cytotoxic T cells detect and eliminate virus-infected cells.

Antibodies from B-cells block the virus from infecting healthy cells.

RNA vaccines contain a strip of genetic material within a lipid bubble.

Inside the cell, ribosomes read the mRNA instructions for the spike protein.

The cell then begins to generate copies of the spike protein.

Antigen-presenting cells (APCs) consume the viral proteins and pass viral peptides to T-helper cells.

The immune system, presented with the peptide, learns to recognize the virus and releases cytotoxic T cells and B cells.

Cytotoxic T cells detect and eliminate virus-infected cells.

Antibodies from B-cells block the virus from infecting healthy cells.

RNA vaccines contain a strip of genetic material within a lipid bubble.

Inside the cell, ribosomes read the mRNA instructions for the spike protein.

The cell then begins to generate copies of the spike protein.

Antigen-presenting cells (APCs) consume the viral proteins and pass viral peptides to T-helper cells.

The immune system, presented with the peptide, learns to recognize the virus and releases cytotoxic T cells and B cells.

Cytotoxic T cells detect and eliminate virus-infected cells.

Antibodies from B-cells block the virus from infecting healthy cells.

Is it safe?

The FDA authorized the vaccine for people age 16 and over after reviewing data from 44,000 participants in a randomized clinical trial. A 53-page analysis by the agency found that some people who received injections had unpleasant but tolerable side effects, including fatigue, headaches, muscle pain, joint pain, chills and fever. Reviewers said the two months of follow-up on 38,000 of those participants provide evidence of “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an [emergency authorization].”

Will the vaccine protect me from getting covid-19?

The two-shot Pfizer-BioNTech vaccine has been shown to be 95 percent effective in randomized trials. The FDA’s independent review found that of more than 20,000 people who received both vaccine doses, only eight contracted covid-19, and just one person fell seriously ill. By contrast, 162 people in the placebo group contracted covid-19, and nine of those people developed serious illness. There was even some evidence the first shot of the vaccine protected against illness, but the FDA said there was insufficient data to draw firm conclusions. It is also not yet known whether the vaccine prevents infection, as well as illness — a question with big implications for viral spread.

Pfizer enrolled approximately 44,000 people in its late-stage clinical study in the United States, Germany, Turkey, South Africa, Brazil and Argentina. Researchers divided the participants into two groups:

One group received two doses of the vaccine.

Another group was given two doses of a placebo.

One dot

represents

eight

people

8 sick with covid-19 from the vaccine group,

1 severely ill

162 sick with covid-19 from the placebo group,

9 severely ill

Pfizer enrolled approximately 44,000 people in its late-stage clinical study in the United States, Germany, Turkey, South Africa, Brazil and Argentina. Researchers divided the participants into two groups:

One group received two doses of the vaccine.

Another group was given two doses of a placebo.

One dot

represents

eight

people

To eliminate any unintentional bias toward the results, neither group knew whether they received the vaccine or the placebo.

 

Participants were exposed to the coronavirus as they went about their normal routines.

8 sick with covid-19 from the vaccine group, 1 severely ill

162 sick with covid-19 from the placebo group, 9 severely ill

Pfizer enrolled approximately 44,000 people in its late-stage clinical study in the United States, Germany, Turkey, South Africa, Brazil and Argentina. Researchers divided the participants into two groups:

One group received two doses of the vaccine.

Another group was given two doses of a placebo.

One dot

represents

eight people

To eliminate any unintentional bias toward the results, neither group knew whether they received the vaccine or the placebo.

 

Participants were exposed to the coronavirus as they went about their normal routines.

8 sick with covid-19 from the vaccine group, 1 severely ill

162 sick with covid-19 from the placebo group, 9 severely ill

Should I still get vaccinated if…

I already had the coronavirus?

The Centers for Disease Control and Prevention says vaccination should be offered to people regardless of whether they had a prior infection. We are still learning how long immunity to the coronavirus lasts, after an infection or a vaccination. Typically, an infection causes better immunity than a vaccine, but not always — the vaccines for tetanus and human papillomavirus, for example, offer better protection than recovering from a natural infection.

What if I have covid-19 now?

It’s best to wait to be inoculated until you’ve recovered from your illness and have met all the criteria to end self-isolation to avoid spreading the infection to others. There is no recommended minimum interval to get vaccinated after you’ve recovered.

I’m pregnant, plan to get pregnant soon or I’m breastfeeding?

Pregnant or breastfeeding women who are part of a group recommended to get the shot — for instance, health-care workers — might want to consider talking with their medical providers beforehand. Pregnant women have been excluded from coronavirus vaccine trials, so there is no data on the safety of the vaccines for them, or its effects on the breastfed infant.

The American College of Obstetricians and Gynecologists says a conversation with a woman’s clinician may be helpful, but should not be required. Pregnant women who get infected with the coronavirus are at greater risk of death and severe illness than women who are not pregnant, even as the overall risk remains small.

The Pfizer vaccine does not contain live virus, or any enhancers to boost an immune response, and is not thought to be a risk to the breastfeeding infant. It does not alter human DNA in the people who get it and cannot cause any genetic changes. Also, this type of vaccine breaks down quickly and doesn’t enter the nucleus of the cell.

Pfizer said it is planning to report to the FDA by the end of the year on a developmental and reproductive toxicity study in animals that could help clarify any risks.

I have allergies. Can I get the new vaccine?

People who have mild allergies to food, pets, environment or latex can get the Pfizer-BioNTech vaccine.

Concern about allergies relate to reports from the United Kingdom of severe allergic reaction in two British health-care workers, both of whom were treated and recovered. Researchers do not know what substance in the vaccine formula triggered the severe allergic response. The CDC says people with a history of severe allergic reaction to any component of the vaccine should not get vaccinated.

If you have a history of severe allergic reaction to another vaccine or injectable therapy, however, that should not necessarily preclude you from getting the shots. But the CDC advises that you consult your doctor beforehand.

What about people with HIV infections or have other immunocompromising conditions, or who take immunosuppressive medications?

The vaccine hasn’t been studied in immunocompromised people, and they are not anticipated to be at increased risk of adverse reactions. However, they should talk to their providers beforehand because their immune systems may not respond optimally.

When will I be able to get vaccinated?

That depends on your job, your age and your health. For the most up-to-date information see The Post’s vaccine distribution tracker.

The vaccines began to be distributed as soon as mid-December to those in high-risk groups — an estimated 200 million people — who will receive priority, according to a framework devised by an advisory committee to the CDC. Government officials said that if both the Pfizer and Moderna vaccines are authorized, they anticipate having enough doses for 20 million people by year’s end.

You may qualify for earlier access because of your job: Health-care workers and first responders are likely to be among those prioritized. People who have essential jobs, such as teachers and food workers; those who are at higher risk because of their age; and those who have underlying conditions that increase their risk for severe disease are also likely to receive earlier access.

Healthy younger adults who don’t have medical conditions or high-risk jobs are likely to begin to get vaccinated starting in April, but not everyone will be able to get the shots immediately. And children aren’t even included in most coronavirus vaccine trials — Pfizer is the first company to expand its trial to people 12 and older — so they probably will be among the last to get access.

“I would say starting in April, May, June, July — as we get into the late spring and early summer — that people in the so-called general population, who do not have underlying conditions or other designations that would make them priority, could get” shots, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

How will the vaccines be shipped?

The vaccine from Pfizer and BioNTech must be kept at an ultracold, minus-70 degrees Celsius, a requirement that will add a wrinkle to an unprecedented vaccination campaign. The company has created its own GPS-tracked coolers filled with dry ice to distribute it.

How Pfizer will ship its vaccine at ultra-low temperatures

The frozen vaccine is packaged into 2-milliliter glass vials — each holding five doses.

One tray holds 195 vials. Up to five trays fit into a box.

The vaccine cartons are surrounded by 50 pounds of dry-ice pellets.

A GPS temperature monitor is placed in each shipment. The vaccine must be kept below minus- 70 degrees Celsius.

How Pfizer will ship its vaccine at ultra-low temperatures

The frozen vaccine is packaged into 2-milliliter glass vials — each holding five doses.

One tray holds 195 vials.

Up to five trays fit into a box.

The vaccine cartons are surrounded by 50 pounds of dry-ice pellets.

A GPS temperature monitor is placed in each shipment. The vaccine must be kept below minus-70 degrees Celsius.

How Pfizer will

ship its vaccine

at ultra-low temperatures

The frozen vaccine is packaged into 2-milliliter glass vials — each holding five doses.

One tray holds 195 vials. Up to five trays fit into a box.

The vaccine cartons are surrounded by 50 pounds of dry-ice pellets.

A GPS temperature monitor is placed in each shipment. The vaccine must be kept below minus-70 degrees Celsius.

How Pfizer will ship

its vaccine at ultra-

low temperatures

The frozen vaccine is packaged into 2-milliliter glass vials — each holding five doses.

One tray holds 195 vials. Up to five trays fit into a box.

The vaccine cartons are surrounded by 50 pounds of dry-ice pellets.

A GPS temperature monitor is placed in each shipment. The vaccine must be kept below minus-70 degrees Celsius.

Each vial of the Pfizer vaccine holds five doses when diluted. Once thawed, the undiluted vial can be kept in a refrigerator for only five days. A diluted vial can be kept for only six hours before it must be discarded.

The Moderna vaccine is stored frozen at minus-20 degrees Celsius, but it keeps for a month at refrigerator temperatures. This could make it easier to distribute to pharmacies and rural areas that don’t have specialized freezers.

How were the vaccines made so fast?

Historically, vaccines have taken years to develop. Before these, the mumps vaccine — which took four years to develop — was the fastest to be approved for use in humans. Developing messenger RNA vaccines like the Pfizer and Moderna candidates has been fast because scientists were able to start their work before there was a known case of the novel coronavirus in this country, using the viral genome shared online as a template. Making messenger RNA vaccines does not require time-consuming steps, such as growing ingredients in chicken eggs.

How much will the vaccines cost?

The federal government has pre-purchased hundreds of millions of vaccine doses with taxpayer money, and vowed to make them available free.

Will I still need to socially distance?

Yes. Even after a vaccine is approved, experts say people will need to wear masks and socially distance — in part because the vaccine doses will be limited, and it will take time to immunize enough of the population to stop the virus from spreading. Experts say the return to normalcy could take many months or longer.

Will I have a choice on which vaccine to take assuming more than one is approved?

Supply will be far short of demand initially, so you are unlikely to be offered options in the near term. Also, the vaccines have different storage and handling requirements making it likely that each administration site will only have one vaccine on hand, at least to start with.

But Kelly Moore of the Immunization Action Coalition believes that once there are plenty of products available, that may change. Moore hopes supply may meet demand by the second half of next year, opening the potential for people to have options, particularly if one vaccine is preferable for certain age groups, for example.

Frances Stead Sellers, Lena H. Sun, Christopher Rowland, Chris Alcantara and Sarah Kaplan contributed to this report.

This story was first published November 17.



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Canada Authorizes Use Of Pfizer COVID-19 Vaccine : Coronavirus Updates : NPR


A nurse in the U.K. prepares to administer Covid-19 vaccinations earlier this month. Canadian health officials on Wednesday authorized the use of the Pfizer-BioNTech vaccine.

Hugh Hastings/Getty Images


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A nurse in the U.K. prepares to administer Covid-19 vaccinations earlier this month. Canadian health officials on Wednesday authorized the use of the Pfizer-BioNTech vaccine.

Hugh Hastings/Getty Images

Canadian health officials have authorized use of the country’s first COVID-19 vaccine. Health Canada announced the move Wednesday, saying a “thorough, independent review of the evidence” determined that the vaccine produced by Pfizer and BioNTech meets the “stringent safety, efficacy and quality requirements for use in Canada.”

The move makes Canada just the third country to authorize the Pfizer-BioNTech vaccine for general use, after the U.K. greenlit it last week and began widely administering immunizations on Tuesday. Bahrain also granted an emergency-use authorization to the vaccine last week.

In the U.S., meanwhile, emergency authorization of the vaccine could come within days. In an analysis released Tuesday, the Food and Drug Administration affirmed the vaccine’s safety and its 95% effectiveness at preventing the coronavirus.

An FDA advisory panel meeting Thursday is expected to support emergency use of the vaccine in the U.S. Then a final authorization decision will be up to agency officials.

It’s important to note that in Canada, as in the U.K. — and likely soon in the U.S. — regulators are only authorizing provisional use in response to the pandemic. A formal approval requires more comprehensive data and regulatory review.

As for Canada, the country’s prime minister, Justin Trudeau, has said that he expects 249,000 doses of the Pfizer-BioNTech vaccine to be on hand by the end of the year. Other vaccines, such as one produced by Moderna, are also under review by Canadian health authorities, who said at a news conference Wednesday that they expect to issue further decisions on those soon.



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FDA Analysis Supports Emergency Use Of Pfizer COVID-19 Vaccine : Shots


The authorization under consideration for the Pfizer/BioNTech vaccine would be for “individuals 16 years of age and older.”

John Nacion/SOPA Images/LightRocket/Getty Images


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The authorization under consideration for the Pfizer/BioNTech vaccine would be for “individuals 16 years of age and older.”

John Nacion/SOPA Images/LightRocket/Getty Images

The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from Pfizer and its partner BioNTech ahead of a Thursday meeting of a group of independent experts that will advise the agency on whether to grant the vaccine an emergency use authorization.

The agency’s analysis finds “no specific safety concerns identified that would preclude issuance of an EUA.” Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing reactions at the site of injection, headaches and fatigue.

The analysis also affirms the previously stated vaccine effectiveness of 95%, assessed a week after two doses of vaccine. The vaccine doses are given 21 days apart.

The clinical data also suggest that the vaccine may be able to prevent COVID-19 after the first dose — 82% effective — though the FDA analysis says the available information doesn’t allow for a firm conclusion on that potential effect.

The vaccine authorization under consideration is “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”

On Thursday, the Vaccines and Related Biological Products Advisory Committee, an advisory group, will discuss the vaccine in an open public meeting.

The agency will ask the experts to assess whether the available scientific evidence supports the proposed emergency use of the vaccine. Specifically, the committee will be asked whether the known and potential benefits of the vaccine outweigh its known and potential risks in people 16 and older.

The FDA will also ask the experts to weigh in on what additional studies should be done by the companies to further elucidate the safety and effectiveness of the vaccine after it is available under an EUA.



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Most Americans won’t get Pfizer vaccine until June, because Trump passed on opportunity to buy more


As The New York Times reports, Trump had a chance to secure millions more doses of Pfizer’s mRNA-based vaccine. Obtaining those doses for the nation didn’t require a long-shot bet made way back at the beginning of the pandemic. That chance came in early November, when good results from Phase 2 trials had already been analyzed and Phase 3 results were just days away.

Trump didn’t pull the trigger. Other nations did. As a result, the United States will have access to enough vaccine for about 50 million people over the next eight months, and will have to wait for summer 2021 before more is available. That number could have been doubled had the U.S. committed to expanding its purchase when given the opportunity.

But just because the horse has definitively left the barn, doesn’t mean that Trump isn’t planning to slam a big door. On Tuesday, Trump is expected to issue an executive order that “proclaims that other nations will not get the U.S. supplies of its vaccine until Americans have been inoculated.” Except that this order appears to be worth even less than Trump’s usual Sharpie-scrawled paperwork. 

The sale of the vaccine to other nations is a done deal. As the BBC notes, the first inoculation with the vaccine outside of a trial occurred on Tuesday morning, with a 91-year-old British woman getting the first dose. 800,000 doses are already on their way to the U.K. — and that’s just one of several international orders. The European Union announced a deal on November 11 for 200 million doses, twice the number that will be available to the U.S. over coming months. Other nations have negotiated additional deals.

There are other vaccines. The U.S. based Moderna is just weeks behind Pfizer with their vaccine, which is based on similar technology and which achieved a staggering 94.5% efficacy in Phase 3 trials. Enough of their vaccine has been ordered to cover another 50 million Americans.

The real big bet that Trump and Operation Warp Speed laid down was on the Oxford / AstraZeneca vaccine, which should have been available to 100 million Americans. However, Phase 3 trials of that vaccine indicated that it may be significantly less effective than either Moderna or Pfizer in protecting against the virus. More importantly, a manufacturing and distribution error in AstraZeneca’s Phase 3 trial makes it difficult to interpret the actual efficacy of their vaccine, and is likely to delay emergency approval by the FDA.

More vaccine doses are expected to be available from Johnson & Johnson and Novavax, both of which are still conducting Phase 3 trials. Johnson & Johnson’s vaccine is notable for only requiring a single dose. However, they are not expected to report Phase 3 results until sometime in January or February.

Failing to secure additional doses of Pfizer’s vaccine in spite of promising results in Phase 1 and Phase 2 testing, means that Americans will be waiting longer, and have fewer options when it comes to receiving a vaccine. No matter what Trump writes on his executive order. That is, unless Trump genuinely intends to order troops to rip crates of vaccines out of the hands of doctors set to deliver it to nations that have already placed an order and negotiated payment. Which would only be an act of war. 





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